%0 Journal Article
%A Ray, Kausik K
%A Leiter, Lawrence A
%A Müller-Wieland, Dirk
%A Cariou, Bertrand
%A Colhoun, Helen M
%A Henry, Robert R
%A Tinahones, Francisco J
%A Bujas-Bobanovic, Maja
%A Domenger, Catherine
%A Letierce, Alexia
%A Samuel, Rita
%A Del Prato, Stefano
%T Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial.
%D 2018
%U http://hdl.handle.net/10668/12122
%X To compare alirocumab, a proprotein convertase subtilisin-kexin type 9 inhibitor, with usual care (UC) in individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia not optimally managed by maximally tolerated statins in the ODYSSEY DM-DYSLIPIDEMIA trial (NCT02642159). The UC options (no additional lipid-lowering therapy; fenofibrate; ezetimibe; omega-3 fatty acid; nicotinic acid) were selected prior to stratified randomization to open-label alirocumab 75 mg every 2 weeks (with increase to 150 mg every 2 weeks at week 12 if week 8 non-HDL cholesterol concentration was ≥2.59 mmol/L [100 mg/dL]) or UC for 24 weeks. The primary efficacy endpoint was percentage change in non-HDL cholesterol from baseline to week 24. The randomized population comprised 413 individuals (intention-to-treat population, n = 409; safety population, n = 412). At week 24, the mean non-HDL cholesterol reductions were superior with alirocumab (-32.5% difference vs UC, 97.5% confidence interval -38.1 to -27.0; P  In individuals with T2DM and mixed dyslipidaemia on maximally tolerated statin, alirocumab showed superiority to UC in non-HDL cholesterol reduction and was generally well tolerated.
%K PCSK9
%K mixed dyslipidaemia
%K non-HDL cholesterol
%K type 2 diabetes
%~